Disinfectant efficacy must be established before a new disinfectant can be put on the market. Additionally, manufacturers must validate disinfectant regimens for cleanroom and other controlled areas. Many different standards apply, including AOAC Chapter 6 tests, ASTM E 2315, USP General Chapter 1072 and ASTM E 26140.

It’s a complicated — but critical — topic for drug, device, biologics and supplement makers, and compounders too. They’ve seen a rise in the number and species of bacterial endospores and mold spores — and a rise in warning letters and Forms 483 too.

Now FDAnews is calling on Jim Polarine Jr., a recognized authority on disinfectant testing and validation, to clear the air.

You’ll address control of resistant species such as Bacillus cereus, and walk through case studies on testing intricacies including porosity of surfaces, surface sterilization, and pooling on surfaces.

Jim Polarine Jr. MA., Senior Technical Service Manager, STERIS Corp.Mr. Polarine focuses on microbial control in cleanrooms and other critical environments. A frequent lecturer on cleaning and disinfection in cleanrooms, he co-chairs the microbial investigations task force of the Parenteral Drug Assn. (PDA) and was a co-author of PDA’s Technical Report #70 on Cleaning and Disinfection. In addition to the PDA, he is a member of SIMB, ISPE, IEST, ASM, ASTM, AAAS, AOAC and ACS. He previously worked as a clinical research coordinator with the Department of Veterans Affairs and as a biology and microbiology instructor at the University of Illinois.